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Recruiting Phase 2 NCT06577311

NCT06577311 Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (SCCis)

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Clinical Trial Summary
NCT ID NCT06577311
Status Recruiting
Phase Phase 2
Sponsor The Center for Clinical and Cosmetic Research
Condition Cutaneous Squamous Cell Carcinoma
Study Type INTERVENTIONAL
Enrollment 20 participants
Start Date 2024-08-14
Primary Completion 2025-08

Trial Parameters

Condition Cutaneous Squamous Cell Carcinoma
Sponsor The Center for Clinical and Cosmetic Research
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-08-14
Completion 2025-08
Interventions
Aminolevulinic acid hydrochloride 10% topical gel with Red Light

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Brief Summary

The goal of this clinical trial is to test how safe and effective it is to treat early form of cancer cells found in the upper skin layer of the face, using a light-sensitive gel used in combination with a light source. The main questions this trial aims to answer are: * to confirm using laboratory testing, how much of the affected facial skin cancer section the treatment was able to remove, and; * seeing how many participants had no remaining affected facial skin cancer sections after treatment. Participants who qualify will be asked to complete 14 visits in total and will receive a total of two treatments, after voluntarily consent has been given.

Eligibility Criteria

Inclusion Criteria: * Must be an adult (18 years of age or older) * Must have a recently diagnosed (no more than six months from first study visit) facial SCCis lesion that meets surgery excision size requirements * Cannot have other dermatological disease in the SCCis target area * Must be willing to follow study instructions and complete study requirements, including not using non-approved lotions and creams on the treatments areas * Voluntary written consent required * Allow photographs of the area of skin cancer being treated on the face * Agree to use acceptable forms of birth control. If female, cannot be pregnant before and during the study Exclusion Criteria: * Pregnant or lactating * Sensitive to any of the study treatment ingredients * Medical laboratory evidence of other non-SCCis tumor in the target lesion biopsy specimen * History of recurrence if the target SCCis lesion * Evidence of dermatological disease or skin condition in the treatment area * Medical laboratory evide

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